53 results on '"Cremonesi, Alberto"'
Search Results
2. 2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study.
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Steiner, Sabine, Honton, Benjamin, Langhoff, Ralf, Chiesa, Roberto, Kahlberg, Andrea, Thieme, Marcus, Zeller, Thomas, Garot, Philippe, Commeau, Philippe, Cremonesi, Alberto, Marone, Enrico Maria, Sauguet, Antoine, and Scheinert, Dierk
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The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676) [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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3. A Case of 51 Years Old Woman with Suspected Cardiac, Pulmonary, Bone and Renal Triple-negative Breast Cancer Metastasis
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Nicoli, Flavia, Mollace, Rocco, Collaku, Elona, Monaco, Maria Lo, Gad, Alessandro, Marchini, Federico, Zanello, Alessandro, angeli, Enzo, Brscic, Elvis, Cremonesi, Alberto, and Bertella, Erika
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- 2024
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4. Stellarex drug-coated balloon: a technology evaluation
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Nerla, Roberto, Castriota, Fausto, Cremonesi, Alberto, and Micari, Antonio
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ABSTRACTThe Stellarex® drug-coated balloon (DCB) is an over-the-wire dual lumen catheter with a distally premounted semi-compliant balloon, which has a low dose (2 μg/mm2of the expanded balloon surface) paclitaxel coating. Its hybrid formulation, made of amorphous and crystalline paclitaxel combined with a polyethylene glycol excipient, provides maintenance of coating integrity and adequate drug release. This balanced combination of amorphous and crystalline paclitaxel is able to maintain drug on the surface during handling and balloon tracking, with an effective drug transfer to vessel wall in the lesion site. Clinical data associated with Stellarex balloon are growing and confirm clinical effectiveness over a long-term follow-up without any possible signal of a reduced safety for treated patients.
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- 2020
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5. ST-Elevation Myocardial Infarction in Patients With COVID-19
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Stefanini, Giulio G., Montorfano, Matteo, Trabattoni, Daniela, Andreini, Daniele, Ferrante, Giuseppe, Ancona, Marco, Metra, Marco, Curello, Salvatore, Maffeo, Diego, Pero, Gaetano, Cacucci, Michele, Assanelli, Emilio, Bellini, Barbara, Russo, Filippo, Ielasi, Alfonso, Tespili, Maurizio, Danzi, Gian Battista, Vandoni, Pietro, Bollati, Mario, Barbieri, Lucia, Oreglia, Jacopo, Lettieri, Corrado, Cremonesi, Alberto, Carugo, Stefano, Reimers, Bernhard, Condorelli, Gianluigi, and Chieffo, Alaide
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- 2020
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6. Transcatheter Aortic Valve-in-Valve Implantation Using Lotus Valve for Failed Surgical Bioprostheses.
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Castriota, Fausto, Nerla, Roberto, Micari, Antonio, Cavazza, Caterina, Bedogni, Francesco, Testa, Luca, Montorfano, Matteo, Del Giglio, Mauro, and Cremonesi, Alberto
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Background Patients with failed bioprostheses are an increasing population at high risk for redo surgery. Valve-in-valve transcatheter aortic valve implantation is a promising alternative but a limited number of first-generation devices have proven efficacy in all cases. Methods Patients with degenerated bioprostheses at high risk for redo surgery were included in the registry after being assigned to valve-in-valve intervention by a local heart team. Main basal and follow-up data (at 1 month and 6 months) of patients undergoing valve-in-valve transcatheter aortic valve implantation with the Lotus valve system (Boston Scientific, Natick, MA) in three high-volume Italian centers were entered in the registry. Results Twelve patients (aged 71.1 ± 14.1 years, 66% male, logistic European System for Cardiac Operative Risk Evaluation score 28.8 ± 22.9) were included in the registry. Implantation success rate was 92%; in 1 patient, the valve was completely retrieved because of unsatisfactory gradients after valve positioning. All procedures were done through femoral access, and all but one required only local anesthesia. In patients with stenosis as pure or mixed mechanism for degeneration (n = 7), mean ventriculoaortic gradient decreased from 46.7 ± 7.0 mm Hg to 16.6 ± 5.7 mm Hg ( p < 0.001). No patients had more than mild aortic regurgitation at hospital discharge. Results where confirmed at 1-month and 6-month follow-up, with improvement of New York Heart Association functional status in all patients (functional class I to II in 100% of patients). Conclusions The valve-in-valve procedure using the Lotus valve is a feasible alternative to repeat surgery in high-risk patients with degenerated bioprostheses. Using the Lotus valve in this challenging and increasingly frequent scenario could offer a safe and effective strategy that should be explored in larger clinical trials. [ABSTRACT FROM AUTHOR]
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- 2017
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7. 2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.
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Micari, Antonio, Nerla, Roberto, Vadalà, Giuseppe, Castriota, Fausto, Grattoni, Chiara, Liso, Armando, Russo, Paolo, Pantaleo, Paolo, Roscitano, Giuseppe, and Cremonesi, Alberto
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Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease. [ABSTRACT FROM AUTHOR]
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- 2017
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8. Independent Modular Filter for Embolic Protection in Carotid Stenting.
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Scheinert, Dierk, Reimers, Bernhard, Cremonesi, Alberto, Schmidt, Andrej, Sievert, Horst, Rohde, Stefan, Schofer, Joachim, Mudra, Harald G., Bosiers, Marc, Zeller, Thomas, Pacchioni, Andrea, and Rosenschein, Uri
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Background--Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014" guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. Methods and Results--A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. Conclusions--The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement. [ABSTRACT FROM AUTHOR]
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- 2017
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9. Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial
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Valgimigli, Marco, Frigoli, Enrico, Leonardi, Sergio, Vranckx, Pascal, Rothenbühler, Martina, Tebaldi, Matteo, Varbella, Ferdinando, Calabrò, Paolo, Garducci, Stefano, Rubartelli, Paolo, Briguori, Carlo, Andó, Giuseppe, Ferrario, Maurizio, Limbruno, Ugo, Garbo, Roberto, Sganzerla, Paolo, Russo, Filippo, Nazzaro, Marco, Lupi, Alessandro, Cortese, Bernardo, Ausiello, Arturo, Ierna, Salvatore, Esposito, Giovanni, Ferrante, Giuseppe, Santarelli, Andrea, Sardella, Gennaro, de Cesare, Nicoletta, Tosi, Paolo, van 't Hof, Arnoud, Omerovic, Elmir, Brugaletta, Salvatore, Windecker, Stephan, Heg, Dik, Jüni, Peter, Campo, Gianluca, Uguccioni, Lucia, Tamburino, Corrado, Presbitero, Patrizia, Zavalloni-Parenti, Dennis, Ferrari, Fabio, Ceravolo, Roberto, Tarantino, Fabio, Pasquetto, Giampaolo, Casu, Gavino, Mameli, Stefano, Stochino, Maria Letizia, Mazzarotto, Pietro, Cremonesi, Alberto, Saia, Francesco, Saccone, Giovanni, Abate, Fabio, Picchi, Andrea, Violini, Roberto, Colangelo, Salvatore, Boccuzzi, Giacomo, Guiducci, Vincenzo, Vigna, Carlo, Zingarelli, Antonio, Gagnor, Andrea, Zaro, Tiziana, Tresoldi, Simone, Vandoni, Pietro, Contarini, Marco, Liso, Armando, Dellavalle, Antonio, Curello, Salvatore, Mangiacapra, Fabio, Evola, Rosario, Palmieri, Cataldo, Falcone, Camillo, Liistro, Francesco, Creaco, Manuela, Colombo, Antonio, Chieffo, Alaide, Perkan, Andrea, De Servi, Stefano, Fischetti, Dionigi, Rigattieri, Stefano, Sciahbasi, Alessandro, Pucci, Edoardo, Romagnoli, Enrico, Moretti, Claudio, Moretti, Luciano, De Caterina, Raffaele, Caputo, Marcello, Zimmarino, Marco, Bramucci, Ezio, Di Lorenzo, Emilio, Turturo, Maurizio, Bonmassari, Roberto, Penzo, Carlo, Loi, Bruno, Mauro, Ciro, Petronio, Anna Sonia, Gabrielli, Gabriele, Micari, Antonio, Belloni, Flavia, Amico, Francesco, Comeglio, Marco, Fresco, Claudio, Klinieken, Isala, Van Mieghem, Nicolas, Diletti, Roberto, Regar, Evelyn, Sabaté, Manel, Gómez Hospital, Joan Antoni, Díaz Fernández, José Francisco, Mainar, Vicente, and de la Torre Hernandez, Jose Maria
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The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme.
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- 2018
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10. The chronic ischaemic cardiovascular disease ESC Pilot Registry: Results of the six-month follow-up
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Komajda, Michel, Kerneis, Mathieu, Tavazzi, Luigi, Balanescu, Serban, Cosentino, Francesco, Cremonesi, Alberto, Ferrari, Roberto, Kownator, Serge, Szwed, Hanna, Mintale, Iveta, Olivari, Zoran, Rittger, Harald, Shlyakhto, Evgeny V, Slapikas, Rimvydas, Steg, Philippe Gabriel, Valgimigli, Marco, Van Belle, Eric, Tsioufis, Konstantinos, Majda, Wojciech, Laroche, Cécile, and Maggioni, Aldo P
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Aim Chronic ischaemic cardiovascular disease (CICD) remains a leading cause of morbidity and mortality worldwide. The CICD Pilot Registry enrolled 2420 patients across 10 European Society of Cardiology countries prospectively to describe characteristics, management strategies and clinical outcomes in this setting. We report here the six-month outcomes.Methods and results From the overall population, 2203 patients were analysed at six months. Fifty-eight patients (2.6%) died after inclusion; 522 patients (23.7%) experienced all-cause hospitalisation or death. The rate of prescription of angiotensin-converting enzyme inhibitors, beta-blockers and aspirin was mildly decreased at six months (all P< 0.02). Patients who experienced all-cause hospitalisation or death were older, more often had a history of non-ST-segment elevation myocardial infarction, of chronic kidney disease, peripheral revascularisation and/or chronic obstructive pulmonary disease than those without events. Independent predictors of all-cause mortality/hospitalisation were age (hazard ratio (HR) 1.17, 95% confidence interval (CI) 1.07–1.27) per 10 years, and a history of previous peripheral revascularisation (HR 1.45, 95% CI 1.03–2.03), chronic kidney disease (HR 1.31, 95% CI 1.0–1.68) or chronic obstructive pulmonary disease (HR 1.42, 95% CI 1.06–1.91, all P< 0.05). We observed a higher rate of events in eastern, western and northern countries compared to southern countries and in cohort 1.Conclusion In this contemporary European registry of CICD patients, the rate of severe clinical outcomes at six months was high and was influenced by age, heart rate and comorbidities. The medical management of this condition remains suboptimal, emphasising the need for larger registries with long-term follow-up. Ad-hoc programmes aimed at implementing guidelines adherence and follow-up procedures are necessary, in order to improve quality of care and patient outcomes.
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- 2018
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11. 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.
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Micari, Antonio, Vadalà, Giuseppe, Castriota, Fausto, Liso, Armando, Grattoni, Chiara, Russo, Paolo, Marchese, Alfredo, Pantaleo, Paolo, Roscitano, Giuseppe, Cesana, Bruno Mario, and Cremonesi, Alberto
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Objectives The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non–target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540 ) [ABSTRACT FROM AUTHOR]
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- 2016
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12. Suboptimal stent deployment is associated with subacute stent thrombosis: Optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study.
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Prati, Francesco, Kodama, Takahide, Romagnoli, Enrico, Gatto, Laura, Di Vito, Luca, Ramazzotti, Vito, Chisari, Alberto, Marco, Valeria, Cremonesi, Alberto, Parodi, Guido, Albertucci, Mario, and Alfonso, Fernando
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Background Acute or subacute stent thrombosis (ST) is a well-described complication usually causing acute coronary syndromes and, in the worst case scenario, sudden cardiac death. In this study, we aimed at exploring the potential role of optical coherence tomography (OCT) in the understanding of the mechanism of ST. Methods Twenty-one consecutive patients, after acute coronary syndromes due to a definite subacute ST, were assessed with OCT and matched 1:2 with 42 patients undergoing OCT for scheduled follow-up. Optical coherence tomography assessment was focused on features indicative of nonoptimal stent deployment: underexpansion, malapposition, edge dissection, and reference lumen narrowing. Results Optical coherence tomography revealed a minimum stent area sensibly smaller in the ST group (5.6 ± 2.6 vs 6.8 ± 1.7 mm 2 ; P = .03) with a higher incidence of stent underexpansion when compared with the control group (42.8% vs 16.7%; P = .05). Dissection at stent edges was more commonly detected in ST group (52.4% vs 9.5%; P < .01). No significant differences between the 2 groups were observed for malapposition (52.4% vs 38.1%; P = .651) and reference lumen narrowing (19.0% vs 4.8%; P = .172). At least 1 OCT finding indicative of suboptimal stent deployment was detectable in 95.2% of patients experiencing ST versus 42.9% of the control group ( P < .01). Conclusions Optical coherence tomography assessment in patients experiencing subacute ST revealed nonoptimal stent deployment in almost all cases with higher incidence of stent underexpansion and edge dissection, potentially explaining the cause of this adverse event. The adoption of an OCT-guided percutaneous coronary intervention protocol could have a potential for the prevention of ST in complex cases. [ABSTRACT FROM AUTHOR]
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- 2015
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13. Endovascular treatment of late coronary-subclavian steal syndrome.
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Faggioli, Gianluca, Pini, Rodolfo, Cremonesi, Alberto, Grattoni, Chiara, Longhi, Matteo, Mauro, Raffaella, Castriota, Fausto, and Stella, Andrea
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Objective Coronary-subclavian steal syndrome (CSSS) is a rare cause of myocardial ischemia subsequent to stenosis or occlusion of the subclavian artery (SA) proximal to internal thoracic artery (ITA) coronary bypass. Only single cases have been reported in published studies to date. We report a significant series of patients with late CSSS treated through an endovascular approach. Methods We reviewed a series of consecutive patients treated for CSSS. The clinical, anatomic, and technical characteristics of the procedures were considered. Follow-up was performed through clinical and laboratory (electrocardiography, echocardiography, duplex ultrasonography) evaluations. Results From January 2005 to March 2013, 10 patients with CSSS were treated; 7 had stable and 3 unstable angina. Of the 10 patients, 8 had left SA stenosis (6 ostial to the origin and 2 in the middle segment), 1 had proximal occlusion of the left SA, and 1 had stenosis in the innominate artery (proximally to a right internal thoracic artery). Arterial access was at the brachial artery through surgical exposure (n = 6), or radial artery percutaneously (n = 3). In 1 case of proximal occlusion of the left SA, simultaneous femoral and percutaneous radial access was necessary. Predilatation of the stenotic lesion was performed in 6. Balloon expandable stents were used in 7 patients with proximal ostial stenosis or occlusion and self-expandable stents in 2 with nonostial lesions. In 1 other patient with proximal heavy calcified stenosis, cutting-balloon predilatation was performed, resulting in dissection of the SA and occlusion of the ITA graft; blood flow was restored in the left upper arm and myocardium by adjunctive dilatation of the SA and endovascular coronary revascularization. No patients developed angina during the follow-up period (15 ± 7 months).Conclusions A tailored endovascular approach can be used to treat CSSS. However, the occurrence of potentially lethal complications is possible and needs prompt correction. [ABSTRACT FROM AUTHOR]
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- 2014
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14. Old and New Drugs for Treatment of Stable Angina: New Anti-Anginal Drugs and Coronary Revascularization
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Gabrio Secco, Gioel, Parisi, Rosario, Mirabella, Francesca, Rognoni, Andrea, Lupi, Alessandro, De Luca, Giuseppe, Marino, Paolo, Fattori, Rossella, Cremonesi, Alberto, and Castriota, Fausto
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Since the first human catheterization performed by Forssman in 1929 angioplasty equipment and medical therapies have undergone considerable evolution and technical improvement allowing interventionalists to perform more complex procedures and solving most of the percutaneous limitations. While percutaneous coronary intervention (PCI) has dramatically changed the outcome in the Acute Coronary Syndrome (ACS) setting, its role in the treatment of chronic stable angina is still debated. Stable coronary artery disease (SCAD) is a major public health issue and its prevalence is still increasing in the industrialized world. The correct treatment sees a multi-strategy approach aimed to a relief of symptoms, prevention of future cardiac events and survival improvement. In so forth, treatment strategies include optimal medical therapy (OMT) alone or combined with percutaneous or surgical coronary revascularization. Despite this, angina remains poorly controlled in the vast majority of CAD patients. Traditional agents such Beta-blockers or Calcium channel blockers or short and long acting nitrates have been used as first-line anti-anginal therapy for several years. Nowadays newer and more effective drugs usually used on top of older medical treatment have become available.
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- 2015
15. 2-Year Results of Paclitaxel-Eluting Balloons for Femoropopliteal Artery Disease: Evidence From a Multicenter Registry.
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Micari, Antonio, Cioppa, Angelo, Vadalà, Giuseppe, Castriota, Fausto, Liso, Armando, Marchese, Alfredo, Grattoni, Chiara, Pantaleo, Paolo, Cremonesi, Alberto, Rubino, Paolo, and Biamino, Giancarlo
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PACLITAXEL ,DRUG-eluting stents ,FEMORAL artery ,DRUG side effects ,TRANSLUMINAL angioplasty ,INTERMITTENT claudication ,ANKLE brachial index ,DISEASES - Abstract
Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization. [ABSTRACT FROM AUTHOR]
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- 2013
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16. Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry.
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Micari, Antonio, Cioppa, Angelo, Vadalà, Giuseppe, Castriota, Fausto, Liso, Armando, Marchese, Alfredo, Grattoni, Chiara, Pantaleo, Paolo, Cremonesi, Alberto, Rubino, Paolo, and Biamino, Giancarlo
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LEG blood-vessels ,POPLITEAL artery ,PACLITAXEL ,DRUG-eluting stents ,TREATMENT effectiveness ,TRANSLUMINAL angioplasty ,DISEASES ,SURGERY - Abstract
Objectives: This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background: Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods: This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results: The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions: PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization. [ABSTRACT FROM AUTHOR]
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- 2012
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17. Early and Long-Term Outcomes After Combined Percutaneous Revascularization in Patients With Carotid and Coronary Artery Stenoses.
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Tomai, Fabrizio, Pesarini, Gabriele, Castriota, Fausto, Reimers, Bernhard, De Luca, Leonardo, De Persio, Giovanni, Spartà, Daniela, Aurigemma, Cristina, Pacchioni, Andrea, Spagnolo, Barbara, Cremonesi, Alberto, and Ribichini, Flavio
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HEALTH outcome assessment ,CORONARY artery bypass ,CAROTID artery stenosis ,ENDARTERECTOMY ,CONFIDENCE intervals ,FOLLOW-up studies (Medicine) ,CLINICAL trials ,PATIENTS - Abstract
Objectives: This study sought to evaluate the 30-day and long-term clinical outcomes of patients with carotid obstructive disease (COD) and concomitant coronary artery disease (CAD) undergoing a combined percutaneous revascularization, in 4 high-volume centers skilled for the treatment of multilevel vascular disease. Background: The optimal management of patients with COD and concomitant CAD remains controversial. A variety of therapeutic strategies, including coronary artery bypass grafting, alone or in combination with carotid artery revascularization, have been reported. Methods: Between January 2006 and April 2010, 239 consecutive patients with COD (symptomatic carotid stenosis in 20.5%) and concomitant CAD were treated with staged or simultaneous carotid artery stenting and percutaneous coronary intervention, and enrolled in this prospective registry. The primary endpoint was the incidence of major cardiac and cerebrovascular events, including any death, myocardial infarction, or stroke occurring between the first revascularization procedure and 30 days after treatment of the second vascular territory affected. Results: The incidence of the primary endpoint at 30 days was 4.2% (95% confidence interval [CI]: 2.02 to 7.56). The rate of death, myocardial infarction, and stroke at long-term follow-up (median 520 days) was 4.2%, 2.1%, and 3.8%, respectively. At long-term follow-up, patients with previous cardiovascular disease had significantly higher rates of major cardiac and cerebrovascular events than did patients with a first clinical episode (17% vs. 6%, hazard ratio: 3.34; 95% CI: 1.46 to 7.63; p = 0.004). Conclusions: In patients with COD and concomitant CAD, a combined percutaneous treatment compares favorably with previous surgical or hybrid experiences. Such strategy may be particularly suited to complex patients at high surgical risk. [ABSTRACT FROM AUTHOR]
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- 2011
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18. Long-term results of carotid artery stenting.
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de Donato, Gianmarco, Setacci, Carlo, Deloose, Koen, Peeters, Patrick, Cremonesi, Alberto, and Bosiers, Marc
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CAROTID artery surgery ,SURGICAL stents ,RANDOMIZED controlled trials ,CAROTID artery ,ENDARTERECTOMY ,COHORT analysis ,CEREBROVASCULAR disease prevention ,DISEASE risk factors - Abstract
Objective: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients. Methods: This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR. Results: At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention. Conclusion: Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]). [Copyright &y& Elsevier]
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- 2008
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19. The type of embolic protection does not influence the outcome in carotid artery stenting.
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Iyer, Vikram, de Donato, Gianmarco, Deloose, Koen, Peeters, Patrick, Castriota, Fausto, Cremonesi, Alberto, Setacci, Carlo, and Bosiers, Marc
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CAROTID artery stenosis ,CAROTID artery diseases ,BLOOD vessels ,CEREBRAL ischemia - Abstract
Objectives: The goal of this study was to review our experience with embolic protection devices (EPDs) during carotid artery stenting (CAS). Specifically, we aimed to verify their clinical effectiveness and to compare clinical outcomes between specific devices and types of EPDs. Methods: The CAS databases at four participating centers were reviewed. Adverse events were defined as death, stroke (>24 hours), or transient ischemic attack (TIA) (<24 hours). We compared the risk of procedural and 30-day events between patients treated with and without an EPD. We also compared these risks between different EPDs and between the different types of EPDs. Results: A total of 3160 CAS procedures using nine EPDs were analyzed. The risk of a procedural adverse event was 0.9% in protected and 2.3% in unprotected procedures (P = .12). Compared with the most frequently used device (FilterWire, Boston Scientific, Natick, Mass), there was no significant difference in the risk of procedural adverse events for any of the other EPDs. There was, however, an increased risk of 30-day adverse events with the Accunet (Abbott Vascular, Redwood, Calif) filter compared with the FilterWire (relative risk [RR] 2.67, confidence interval [CI] 1.41 to 5.04, P = .005). Pairwise comparison of proximal occlusion balloons to filters, distal occlusion balloons to filters, and proximal to distal occlusion balloons revealed no significant difference in the risk of procedural or 30-day adverse events. There was no significant difference in risk of procedural events between eccentric and concentric filters, however, the relative risk of eccentric compared with concentric filters at 30 days was 0.59 (unadjusted, CI 0.38 to 0.92, P = .04). This difference was still apparent after adjustment for risk factors (RR 0.61, CI 0.39 to 0.95, P = .06), but not after adjustment for risk factors and stent-type [(open-cell vs closed-cell) RR 0.76, CI 0.47 to 1.22, P = .51]. Conclusion: The use of EPDs is associated with a low risk of procedural adverse events. We were unable to detect significant differences in risks of procedural adverse events between different devices or types of devices. We speculate that the observed differences seen at 30 days are largely attributable to differences in stent-type used. [Copyright &y& Elsevier]
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- 2007
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20. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results.
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Gray, William A., Hopkins, L. Nelson, Yadav, Sanjay, Davis, Thomas, Wholey, Mark, Atkinson, Richard, Cremonesi, Alberto, Fairman, Ronald, Walker, Gary, Verta, Patrick, Popma, Jeff, Virmani, Renu, and Cohen, David J.
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MYOCARDIAL infarction ,CORONARY disease ,HEART diseases ,NECROSIS - Abstract
Background: Carotid endarterectomy is the standard of care for most patients with severe extracranial carotid bifurcation disease. However, its safety and efficacy in patients with significant surgical risk are unclear. The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk patients) trial was performed to determine whether carotid artery stenting with embolic protection is a safe and effective alternative to endarterectomy in high-surgical-risk patients. Methods: The ARCHeR trial is a series of three sequential, multicenter, nonrandomized, prospective studies. Forty-eight sites enrolled 581 high-surgical-risk patients between May 2000 and September 2003. Patients with severe carotid artery stenosis (angiographically defined, symptomatic ≥50%, or asymptomatic ≥80%) had an ACCULINK nitinol stent implanted. The ACCUNET filter embolic protection system was added to the procedure in the final 2 studies (422 patients). The primary efficacy end point was a composite of periprocedural (≤30 days) death, stroke, and myocardial infarction, plus ipsilateral stroke between days 31 and 365. Results: The 30-day rate of death/stroke/myocardial infarction was 8.3% (95% confidence interval [CI], 6.2%-10.8%), and that of stroke/death was 6.9% (95% CI, 5.0%-9.3%). Most (23/32) strokes were minor, of which more than half (12/23) returned to baseline National Institutes of Health Stroke Scale scores within 30 days. The 30-day major/fatal stroke rate was 1.5% (95% CI, 0.7%-2.9%). No hemorrhagic strokes were observed in the study. Ipsilateral cerebrovascular accident occurred in 1.3% between 30 days and 1 year, thus giving a primary composite end point of 30-day death/stroke/myocardial infarction plus ipsilateral stroke at 1 year of 9.6% (95% CI, 7.2%-12.0%), which is below the 14.4% historical control comparator. Target lesion revascularization at 12 months and 2 years was 2.2% and 2.9%, respectively. Conclusions: The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients. [Copyright &y& Elsevier]
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- 2006
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21. Surgical management of acute carotid thrombosis after carotid stenting: A report of three cases.
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Setacci, Carlo, de Donato, Gianmarco, Setacci, Francesco, Chisci, Emiliano, Cappelli, Alessandro, Pieraccini, Massimo, Castriota, Fausto, and Cremonesi, Alberto
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BLOOD coagulation ,CARDIOVASCULAR diseases ,THROMBOSIS ,CEREBRAL ischemia - Abstract
We report three cases of symptomatic acute carotid thrombosis occurring after carotid artery stenting (CAS). Case 1: A patient presented with crescendo transient ischemic attacks on the second day after CAS. Ultrasound images demonstrated incomplete in-stent thrombosis due to plaque protrusion. The urgent surgical procedure consisted of stent removal and carotid thromboendarterectomy. Case 2: A case of complete thrombosis of a carotid stent occurred 4 days after implantation in a patient with essential thrombocythemia diagnosed by chance. The surgical strategy included stent removal and carotid thromboendarterectomy. Case 3: Cardiac multiple embolisms in a patient with chronic atrial fibrillation caused concomitant leg ischemia and acute carotid stent occlusion 2 hours after CAS. Cerebral reperfusion was established by embolectomy, without removing the stent. At the same time, the right leg ischemia was resolved by a thromboembolectomy with a Fogarty catheter. These three cases demonstrate that acute thrombosis after carotid stenting can be managed successfully with emergent surgical intervention. Thromboendarterectomy with stent removal or in selected cases, simple thromboembolectomy, can minimize neurologic sequelae in patients suffering from acute post-stenting carotid thrombosis. [Copyright &y& Elsevier]
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- 2005
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22. 3-Year Follow-Up of the Balloon Elution and Late Loss Optimization Study (BELLO).
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Latib, Azeem, Ruparelia, Neil, Menozzi, Alberto, Castriota, Fausto, Micari, Antonio, Cremonesi, Alberto, De Felice, Francesco, Marchese, Alfredo, Tespili, Maurizio, Presbitero, Patrizia, Sgueglia, Gregory A., Buffoli, Francesca, Tamburino, Corrado, Varbella, Ferdinando, and Colombo, Antonio
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- 2015
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23. Proving the Safety of Carotid Artery Stenting: Now or Never
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Roffi, Marco, Cremonesi, Alberto, and Setacci, Carlo
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- 2012
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24. Guía de práctica clíníca de la ESC sobre diagnóstico y tratamiento de las enfermedades arteriales periféricas
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Tendera, Michel, Aboyans, Victor, Bartelink, Marie-Louise, Baumgartner, Iris, Clément, Denis, Collet, Jean-Philippe, Cremonesi, Alberto, De Carlo, Marco, Erbel, Raimund, Fowkes, F. Gerry R., Heras, Magda, Kownator, Serge, Minar, Erich, Ostergren, Jan, Poldermans, Don, Riambau, Vincent, Roffi, Marco, Röther, Joachim, Sievert, Horst, van Sambeek, Marc, and Zeller, Thomas
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- 2012
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25. Classification for Carotid Artery Stenting Complications: Manifestation, Management, and Prevention
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Nicosia, Antonino, Nikas, Dimitrios, Castriota, Fausto, Biamino, Giancarlo, Cao, Piergiorgio, Cremonesi, Alberto, Mathias, Klaus, Moussa, Issam, Hopkins, L. Nelson, Setacci, Carlo, Sievert, Horst, and Reimers, Bernhard
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Carotid artery stenting is a rapidly evolving method for treating carotid artery disease. Various intraprocedural and postprocedural complications have been reported in the literature. However, the absence of a unified classification scheme for these complications makes it difficult, if not impossible, to study their precise incidence, predictors, and management. The aim of this article is to propose the first joint classification of periprocedural complications, to analyze their incidence and etiology, and suggest possible ways to manage and prevent them. This classification is intended to be used as a common platform for prompt recognition, evaluation, treatment, and universal study of the complications during carotid stenting procedures. For this purpose, the opinions of the major experts on carotid interventions worldwide were merged with all the available information reported in the English-language literature to present as accurately as possible the management and prevention of carotid stenting complications according to this proposed classification.
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- 2010
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26. Cutting Balloon Angioplasty in Percutaneous Carotid Interventions
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Castriota, Fausto, de Campos Martins, Estêvão Carvalho, Setacci, Carlo, Manetti, Raffaella, Khamis, Hazem, Spagnolo, Barbara, Furgieri, Alessandro, Gieowarsingh, Shane, Parizi, Sepideh Torabi, Bianchi, Paolo, Setacci, Francesco, de Donato, Gianmarco, and Cremonesi, Alberto
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Purpose: To report a prospective feasibility study of Cutting Balloon angioplasty (CBA) applied in the predilation phase of carotid artery stenting (CAS) in highly calcified lesions.Methods: From January 2003 to February 2007, 178 consecutive patients (109 men; mean age 73.1±7.3 years) with highly calcified carotid lesions underwent CAS with CBA applied as a pre-specified strategy in the predilation phase of the procedure. All steps in the procedure were performed under cerebral filter protection. The cutting balloon ranged in diameter from 3 to 4 mm and was inflated at nominal pressures in the target lesion. Pre-CBA dilation with a low-profile coronary balloon was performed only when the Cutting Balloon was not able to cross the lesion. Selection of the filters and stents was at the operator's discretion. Primary endpoints were the all stroke and death rates at 30 days and 6 months. Secondary endpoints included Cutting Balloon success (positioning and full balloon inflation), CAS technical success (residual angiographic stenosis <30%), CAS procedural success (technical success and no complications), and in-hospital major complications.Results: Cutting Balloon success was achieved in all 178 patients. In 32 (18.0%), pre-CBA dilation was necessary due to inability to cross the lesion with the Cutting Balloon initially. CAS technical success was achieved in all patients. One (0.6%) patient suffered transient neurological intolerance due to flow cessation from massive debris in the distal filter; this event was completely resolved after the filter was removed (CAS procedural success 99.4%). One patient suffered a major stroke at day 15 (0.6% 30-day all stroke and death rate). At the 6-month follow-up, 174 (97.7%) patients were evaluated; 1 patient died from myocardial infarction at day 35, and 2 patients died from non-neurological or cardiac causes at days 103 and 158. The cumulative all stroke and death rate was 2.2%.Conclusion: These data suggest that CBA performed during the predilation phase of CAS in highly calcified lesion is a safe and useful method to prepare this lesion subset for stenting.
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- 2008
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27. Multicenter Experience with a New “Hybrid” Carotid Stent
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Cremonesi, Alberto, Rubino, Paolo, Grattoni, Chiara, Scheinert, Dierk, Castriota, Fausto, and Biamino, Giancarlo
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Purpose: To report the results from a prospective multicenter registry evaluating the safety and performance of a new hybrid stent specifically engineered for carotid indications.Methods: Between October 18, 2006, and March 28, 2007, 124 patients (88 men; mean age 71.8±7.3 years, range 52–87) underwent Cristallo Ideale stent implantation at 4 expert sites in Italy and Germany. Eligibility criteria included >60% symptomatic and >80% asymptomatic carotid stenosis. Different cerebral protection devices were utilized (proximal protection and distal filters). The primary endpoint was the rate of 30-day major adverse neurological events, defined as major and minor stroke and neurological death by independent neurological assessment. All adverse events were adjudicated by an independent clinical event committee.Results: Stent deployment was completed successfully in all the cases without documented technical failure. There were no neurological events during the procedures. Thirty-day follow-up was available for 119 (96.0%) patients [2 (1.6%) were lost to follow-up and 3 (2.4%) died from non-neurological causes unrelated to the device or procedure]. There were no major adverse neurological events within 30 days, but 2 (1.6%) device-/procedure-related transient ischemic attacks were reported (both resolved completely in <24 hours). Four (3.2%) other non-neurological events (anemia requiring transfusion, worsening of pre-existing chronic renal failure, acute access site thrombosis, and monocular vision disturbance) were reported in the study period.Conclusion: The Cristallo Ideale carotid stent is safe and effective in the periprocedural period. Its newly designed hybrid structure seems to support the rationale of combining adequate plaque scaffolding with high vessel adaptability.
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- 2008
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28. Impact of Diabetes, Patient Age, and Gender on the 30-Day Incidence of Stroke and Death in Patients Undergoing Carotid Artery Stenting with Embolus Protection: A Post-Hoc Subanalysis of a Prospective Multicenter Registry
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Schlüter, Michael, Reimers, Bernhard, Castriota, Fausto, Tübler, Thilo, Cernetti, Carlo, Cremonesi, Alberto, Berger, Jürgen, Colombo, Antonio, and Schofer, Joachim
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Purpose: To assess the impact of diabetes, patient age, and gender on major periprocedural (30-day) complications (major and minor strokes, all-cause deaths) following carotid artery stenting (CAS).Methods: An exploratory analysis was performed of 695 patients (516 men; mean age 69.9±8.4 years) enrolled consecutively between September 1999 and September 2002 in a multicenter Italian/German registry of routine CAS using cerebral protection devices. There were 535 nondiabetic patients and 160 diabetic patients in the analysis.Results: Logistic regression analysis revealed that diabetes and age, but not gender, impacted the cumulative 30-day incidence of any stroke and death (OR 2.1, 95% CI 1.0 to 4.8, p=0.068 and OR 1.06, 95% CI 1.01 to 1.12, p=0.031, respectively), as well as the 30-day incidence of major strokes and deaths (OR 5.9, 95% CI 1.6 to 21.8, p=0.007 and OR 1.13, 95% CI 1.02 to 1.25, p=0.018, respectively). According to receiver-operating characteristic analysis, age had no discriminatory power to predict complications in nondiabetic patients, but an age of 75 years was identified as the optimal cut point to predict complications in diabetic patients. Compared with nondiabetic patients, diabetics ≥75 years had a 4.3 greater risk of experiencing any stroke or death (95% CI 1.3 to 12.3, p=0.016) and a 12.0 greater risk of a major stroke or death (95% CI 2.1 to 66.5, p=0.005). Diabetics < 75 years had no increase in risk over that of nondiabetic patients.Conclusion: Diabetic patients ≤75 years carry a significantly increased risk for strokes or death after protected CAS. The findings should be taken into consideration when treating elderly diabetic patients.
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- 2007
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29. Carotid Artery Stenting
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Cremonesi, Alberto, Setacci, Carlo, Bignamini, Angelo, Bolognese, Leonardo, Briganti, Francesco, Di Sciascio, Germano, Inzitari, Domenico, Lanza, Gaetano, Lupattelli, Luciano, Mangiafico, Salvatore, Pratesi, Carlo, Reimers, Bernard, Ricci, Stefano, de Donato, Gianmarco, Ugolotti, Ugo, Zaninelli, Augusto, and Gensini, Gian Franco
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The prevention of stroke and the correct treatment of carotid artery stenosis represent today a major debate in cardiovascular medicine. Beside carotid endarterectomy, carotid angioplasty and stenting is becoming more widely performed for the treatment of severe carotid obstructive disease, and is now accepted as a less invasive technique that may provide an alternative for selected patients, particularly those with significant comorbidities. An Italian multidisciplinary task force, in which converged the most representative scientific societies involved in carotid treatment, was created to provide neurologists, radiologist, cardiologists, vascular surgeons, and all those involved in prevention and treatment of carotid disease with a simple, clear and updated evidence-based consensus document.
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- 2006
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30. Is Carotid Artery Stenting in Octogenarians Really Dangerous?
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Setacci, Carlo, de Donato, Gianmarco, Chisci, Emiliano, Setacci, Francesco, Pieraccini, Massimo, Cappelli, Alessandro, Palasciano, Giancarlo, Castriota, Fausto, and Cremonesi, Alberto
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Purpose: To evaluate (1) whether carotid artery stenting (CAS) performed in octogenarians increases the procedure-related risk and (2) the incidence of complex anatomy of the aortic arch and supra-aortic vessels in patients >80 years old, which can increase the technical difficulty of CAS.Methods: Between December 2000 and September 2005, 1053 patients (903 men; mean age 72±2.2 years, range 46–90) underwent 1222 CAS procedures in 2 centers for de novo (n=1192) and restenotic (n=30) lesions (139 staged bilateral procedures). Indications for treatment were the presence of a symptomatic carotid artery stenosis ≥70% (n=798, 65.3%) or an asymptomatic stenosis of at least 80%. The patients were separated into 2 age categories: under 80 (n=1078 procedures, 88.2%) and 80 or older (n=144 procedures, 11.8%) for this analysis. Data analysis included death and stroke rate at discharge and at 30 days. Anatomical characteristics evaluated were aortic arch elongation, arch and supra-aortic vessel calcification and tortuosity, anatomical tortuosity of the lesion, and carotid plaque composition.Results: Three lesions in octogenarians could not be treated because of failure to access the vessel in 1 case and extremely tortuous arteries in 2. The overall death and stroke rate at 30 days was 2.12% in the older group (2 fatal strokes, 1 minor stroke) and 1.11% in the younger group (3 deaths, 3 major strokes, 6 minor strokes); the difference was not statistically significant (p=0.40). Significantly higher frequencies of tortuosity and calcification of the arch and supra-aortic vessels and of type III aortic arch were observed in the older group (p<0.001).Conclusion: In our experience, CAS has proven to be safe and effective in elderly patients. Different age-related anatomical features can represent an adjunctive technical challenge, but these difficulties can be successfully managed without increased perioperative risk if CAS is performed in high-volume centers by highly skilled operators.
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- 2006
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31. Rationale and Design of a Multidisciplinary National Real-World Registry on Carotid Stenting: The Italian Registry for Carotid Stenting (RISC)
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Biasi, Giorgio M., Deleo, Gaetano, Froio, Alberto, Cremonesi, Alberto, Inglese, Luigi, Lavitrano, Marialuisa, and Setacci, Carlo
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The Registro Italiano per lo Stenting Carotideo (RISC, Italian Registry for Carotid Stenting) has been organized by Italian specialists from different disciplines directly involved in the prevention of stroke due to carotid plaques through stenting of carotid lesions. The Registry has been endorsed by the national societies of 4 different specialties: vascular surgery, interventional cardiology, radiology, and neuroradiology. Each society contributed in the planning stage.The basis for the registry is to collect data on carotid stenting procedures performed by different specialists with different techniques in a “real-world” setting without the limitations of a randomized clinical trial. The Registry was funded to enroll at least 1200 patients over a minimum period of 36 months. The results will be analyzed using the intention-to-treat principle and are anticipated in late 2006. Primary endpoints of the registry are the 30-day combined death and stroke rate and the occurrence of restenosis and ipsilateral neurological deficit at 12 and 24 months. Considerable attention has been paid to the registry's quality control program to ensure scientific validation. An online database facilitates the collection of data with speed and accuracy.
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- 2006
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32. Endovascular Treatment of Soft Carotid Plaques: A Single-Center Carotid Stent Experience
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Cremonesi, Alberto, Manetti, Raffaella, Liso, Armando, Ricci, Enrico, Bianchi, Paolo, and Castriota, Fausto
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Purpose: To report a prospective evaluation of the 30-day clinical neurological outcome in patients percutaneously treated for severe symptomatic and asymptomatic soft echolucent carotid plaques under cerebral protection from a proximal flow blockade system.Methods: From December 2001 to February 2005, 84 consecutive patients (63 men; mean age 70.7±7.1 years, range 58–81) with documented soft echolucent (gray scale median <25) extracranial carotid lesions were enrolled in a study of percutaneous stenting under cerebral protection achieved by a proximal endovascular clamping device. Primary end-point of the study was the all stroke and death rate at 30 days. Secondary endpoints were angiographic success and any complication between discharge and 30 days. All adverse events were analyzed by an independent neurological team.Results: Total neurological events at 30-day follow-up included 3 transient ischemic attacks and 1 minor stroke (4.8% neurological event rate). The 30-day rates of stroke and neurological death/stroke were both 1.2%; the all death/stroke rate was 2.4%. Clamping intolerance was observed in 5.9% of cases, but there was no interruption in the procedure or clinical sequelae. In 66.7% of patients, visible debris was collected during the procedure.Conclusion: Protected CAS with proximal flow blockage can successfully be applied in selected patients for soft carotid plaques at high risk for intraprocedural embolic events.
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- 2006
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33. Proximal Endovascular Flow Blockage for Cerebral Protection during Carotid Artery Stenting: Results from a Prospective Multicenter Registry
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Reimers, Bernhard, Sievert, Horst, Schuler, Gerhard C., Tübler, Thilo, Diederich, Klaus, Schmidt, Andrej, Rubino, Paolo, Mudra, Harald, Dudek, Dariusz, Coppi, Gioacchino, Schofer, Joachim, Cremonesi, Alberto, Haufe, Mathias, Resta, Maurizio, Klauss, Volker, Benassi, Alberto, Di Mario, Carlo, Favero, Luca, Scheinert, Dierk, Salemme, Luigi, and Biamino, Giancarlo
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Purpose: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries.Methods: In 14 European centers, 157 patients (121 men; mean age 68.0±8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure.Results: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%±7.8% to 6.7%±5.1%. The mean duration of flow blockage was 7.6±5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%.Conclusions: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.
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- 2005
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34. Determinants of In-Stent Restenosis after Carotid Angioplasty: A Case-Control Study
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Setacci, Carlo, Pula, Giorgio, Baldi, Irene, de Donato, Giammarco, Setacci, Francesco, Cappelli, Alessandro, Pieraccini, Massimo, Cremonesi, Alberto, Castriota, Fausto, and Neri, Eugenio
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Purpose: To report a retrospective study that sought to identify clinical factors contributing to the development of in-stent restenosis in the carotid arteries, to profile the patients at greatest risk, and to review the treatment modalities evolved from our experience.Methods: Between December 2000 and April 2003, 195 carotid angioplasty/stenting (CAS) procedures (12 bilateral) were performed in 183 patients (131 men; median age 65.9 years, interquartile range 55.2–72.7). Stenting for de novo stenoses was performed in 119 (61%) carotid arteries; 76 (39%) vessels were treated for postsurgical restenosis. Nearly two thirds of the patients (117, 64%) were symptomatic. Patients were evaluated at 3 and 6 months and at 6-month intervals thereafter with duplex ultrasonography. Angiography was used to confirm any recurrent lesion detected on the ultrasound scan.Results: Overall perioperative neurological complications included 4 (2.2%) minor strokes, 1 (0.5%) intracranial hemorrhage, and 1 (0.5%) major stroke; both patients with major neurological complications died at 5 and 12 days, respectively, after the procedure. During the 12.5-month follow-up (range 0–27.2), 3 non-procedure-related late deaths and another 9 (4.9%) neurological events occurred (2 strokes and 7 transient ischemic attacks). In-stent restenosis after CAS was present in 10 (5.2%) of 193 carotid arteries (9/181 patients) in follow-up; all but 1 artery had been treated for postsurgical restenosis. All lesions were treated secondarily with endovascular procedures. Statistical analysis demonstrated that postsurgical restenosis was the only predictive factor for the development of in-stent restenosis (OR 15.5, 95% CI 2.05 to 125.6, p = 0.001) in this cohort.Conclusions: The present study, far from being exhaustive on the subject, indicates that patients who develop restenosis after carotid endarterectomy are also prone to develop restenosis after CAS; moreover, although strongly recommended for postsurgical restenosis, CAS carries a greater risk of in-stent restenosis in this subgroup, thus reducing the benefits of this procedure.
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- 2003
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35. Impact of Cerebral Protection Devices on Early Outcome of Carotid Stenting
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Castriota, Fausto, Cremonesi, Alberto, Manetti, Raffaella, Liso, Armando, Oshola, Kareem, Ricci, Enrico, and Balestra, Guido
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Purpose: To evaluate the impact of cerebral protection devices on the procedural safety and outcome of carotid stent procedures.Methods: From June 1997 to July 2001, 275 consecutive patients (208 men; mean age 71 ± 7.4 years) underwent percutaneous angioplasty and/or stenting of the extracranial carotid artery. In the first 125 (45.4%) patients, the procedures were performed without cerebral protection. After January 2000, protection devices were routinely used (150 [54.6%] patients), including the Angioguard filter, GuardWire occlusion system, TRAP Vascular Filtration System, EPI Filter Wire, NeuroShield, Parodi Anti-Embolism System, and Medicorp occlusive balloon.Results: The percutaneous procedures were effective in 273 (99.3%) patients. No death or major stroke occurred in either group. In the unprotected group, 5 (4.0%) complications occurred: 3 (2.4%) minor strokes, 1 (0.8%) transient ischemic attack (TIA), and 1 (0.8%) subarachnoid hemorrhage. In the patients treated under cerebral protection, there were 2 (1.3%) complications: 1 (0.7%) minor stroke and 1 (0.7%) subarachnoid hemorrhage. There were 4 (3.2%) periprocedural embolic complications in the unprotected group versus 1 (0.7%) in the protected patients.Conclusions: Our data suggest that percutaneous dilation and stenting of the carotid arteries protected by cerebral protection devices is feasible and effective. In a consecutive series, the use of the cerebral protection systems reduced the acute neurological event rate related to embolic complications by 79%.
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- 2002
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36. Efficacy of a Nitinol Filter Device in the Prevention of Embolic Events during Carotid Interventions
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Cremonesi, Alberto and Castriota, Fausto
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Purpose: To evaluate the feasibility, safety, and efficacy of the TRAP Vascular Filtration System (VFS) during carotid interventions as a deterrent to embolic complications.Methods: Thirty-one consecutive patients (18 men; mean age 72 ± 8 years) gave informed consent to undergo elective percutaneous angioplasty and stenting of the extracranial carotid artery protected by the TRAP VFS, a nitinol basket filter system.Results: The TRAP VFS was delivered and retrieved safely in all patients; procedural success for carotid stenting was 100%. In 3 (9.7%) cases, the filters were positioned after lesion predilation. Nearly half (13, 41.9%) of the retrieved filters contained visible plaque debris that histology identified as cholesterol crystals, fibrin material, atheromatous plaque, and macrophage foam cells. There were no symptomatic major or minor neurological complications encountered in this cohort during hospitalization.Conclusions: Our data indicate that percutaneous dilation and stenting of the carotid artery protected by TRAP VFS appears to be feasible, safe, and effective in preventing cerebral embolization.
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- 2002
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37. Clinical experience with the NIR stent: Retrospective observation on acute results and follow-up in 709 patients
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Cremonesi, Alberto, Alberti, Alessandro, Castriota, Fausto, Ricci, Enrico, El Jamal, Bilal, Grattoni, Chiara, Manetti, Raffaella, Nannini, Cristina, and Filippini, Claudia
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- 2000
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38. Clinical Experience with the NIR Stent: Retrospective Observation on Acute Results and Follow-up in 709 Patients
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Cremonesi, Alberto, Alberti, Alessandro, Castriota, Fausto, Ricci, Enrico, Jamal, Bilal El, Grattoni, Chiara, Manetti, Raffaella, Nannini, Cristina, and Filippini, Claudia
- Abstract
Abstract. The NIR stent is an expandable cellular coronary prosthesis with high flexibility and excellent trackability. The very low crossing profile, associated to the high flexibility, makes this stent suitable for complex and distal lesions. The aim of this study was to evaluate the feasibility, safety, and long-term (clinical follow-up) efficacy of elective and/or urgent deployment of the NIR stent in a broad patient group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211 women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories. Procedural angiographic success was achieved in 98.4% of all the lesions treated, ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data were obtained at 8.6 ± 2.8 months following the stenting procedure. The event-free survival rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization 9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient population were excellent, showing very high procedural success rate both in normal and complex coronary anatomy. On the basis of the previous data, we can define NIR stent a safe multifunctional device suitable both for easy and complex situations. The clinical late results are very promising in term of event-free survivals and late MACE.
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- 2000
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39. Device-Based Left Atrial Appendage Closure.
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Pappone, Carlo, Vicedomini, Gabriele, Cremonesi, Alberto, Zuffada, Francesca, and Santinelli, Vincenzo
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OLDER patients ,CARDIAC hypertrophy ,ATRIAL fibrillation ,REFRACTORY coating ,ATROPINE - Abstract
The article describes the case of an elderly patient with symptomatic paroxysmal atrial fibrillation who have undergone transcatheter left atrial appendage (LAA) closure. Some of the symptoms presented include hypertrophic cardiomyopathy and refractory atrial fibrillation. A marked hypotension was observed due to a possible massive distal coronary air embolization. The blood pressure of the patient finally stabilized after the administration of oxygen and intravenous atropine.
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- 2011
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40. Working in the Mirror: Left Atrial Appendage Closure in a Patient With Dextrocardia.
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Castriota, Fausto, Nerla, Roberto, Squeri, Angelo, Micari, Antonio, Del Giglio, Mauro, and Cremonesi, Alberto
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- 2016
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41. Needing a Helping Hand: Left Amplatz Catheter to Facilitate Anterior Leaflet Grasping in the MitraClip Procedure.
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Castriota, Fausto, Nerla, Roberto, Squeri, Angelo, Micari, Antonio, Del Giglio, Mauro, and Cremonesi, Alberto
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- 2016
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42. Carotid stent cell design: lack of benefit or lack of evidence?
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Cremonesi A, Setacci C, Castriota F, Valgimigli M, Cremonesi, Alberto, Setacci, Carlo, Castriota, Fausto, and Valgimigli, Marco
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- 2008
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43. Independent Modular Filter for Embolic Protection in Carotid Stenting
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Scheinert, Dierk, Reimers, Bernhard, Cremonesi, Alberto, Schmidt, Andrej, Sievert, Horst, Rohde, Stefan, Schofer, Joachim, Mudra, Harald G., Bosiers, Marc, Zeller, Thomas, Pacchioni, Andrea, and Rosenschein, Uri
- Abstract
Supplemental Digital Content is available in the text.
- Published
- 2017
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44. Device-Based Left Atrial Appendage Closure
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Pappone, Carlo, Vicedomini, Gabriele, Cremonesi, Alberto, Zuffada, Francesca, and Santinelli, Vincenzo
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- 2011
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45. Carotid artery stenting: current role of proximal neuroprotection and technical advancements in stroke prevention
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Cremonesi, Alberto, Mussardo, Marco, Sbarzaglia, Paolo, Spagnolo, Barbara, Cavazza, Caterina, and Castriota, Fausto
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For more than 50 years, carotid endarterectomy has been considered the gold standard therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) has emerged in the last 15 years as minimally invasive alternative to surgery, especially in patients at high surgical risk. Recent randomized trials have challenged this concept reporting a relatively high incidence rate (4–6%) of post-CAS neurological adverse events. The aim of this study is to evaluate the current role of CAS in all-comers with advanced carotid disease, managed with mandatory proximal neuroprotection in a high-volume centre. From our database, the last 393 consecutive patients, from January 2011 to August 2013, undergoing CAS under proximal neuroprotection were analysed (mean age 72 ± 8 years). Indications included symptomatic stenoses =60% (n = 87; 22%) and asymptomatic stenoses =80% (n = 306; 78%). In an intention-to-treat approach, CAS success rate was 100%. The in-hospital all stroke/death rate was 1% (minor stroke 1%, major stroke 0%, and death 0%), and the rate of myocardial infarction was 0.3%. The minor stroke rate was 2.3% in symptomatic patients and 0.7% in asymptomatic patients. Carotid artery stenting performed in a high experience centre with the use of proximal embolic protection device is safe and has a low incidence rate of stroke.
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- 2015
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46. Early and late clinical outcomes of endovascular, surgical, and hybrid revascularization strategies of combined carotid and coronary artery diseases: the FRIENDS study group (Finalized Research In ENDovascular Strategies)
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Castriota, Fausto, Tomai, Fabrizio, Gabrio Secco, Gioel, Reimers, Bernhard, Piccoli, Anna, De Persio, Giovanni, Pesarini, Gabriele, Schiavina, Giulia, Borioni, Raoul, Pacchioni, Andrea, Cremonesi, Alberto, Vassanelli, Corrado, and Ribichini, Flavio
- Abstract
The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. The aim of the study is to observe post-procedural and 1-year clinical outcomes of patients with COD and CAD after an endovascular, surgical, or a combined (hybrid) revascularization approach, selected by consensus of a multidisciplinary team. Between January 2006 and December 2012, 1043 consecutive patients with COD and concomitant CAD were treated. According to treatment strategies, patients were divided into three groups: surgical: 391 patients (37.1%), endovascular: 502 (48.1%), and hybrid (combined surgical and percutaneous revascularization): 129 (12.4%). The remaining 21 patients were managed medically only and not analysed. The primary end point of the study was a composite of death, myocardial infarction (MI), and stroke at 1-year follow-up; secondary end points included a composite of death, MI, and stroke in-hospital, and major bleeding complications. In hospital, mortality was higher in the surgical group (2.3 vs. 0.2 and 0%, P < 0.001), more strokes occurred in the endovascular group (2.0 vs. 0.5 and 0.8%, P = 0.03), and major bleedings were more frequent among hybrid patients (13.9 vs. 3.8 and 5.5%, P = 0.001). The incidence rate of the primary end point (hierarchical at 1 year) occurred in 6.0% of the study population (5.8, 6.5, and 4.6%, respectively; P = ns for all groups). Surgical and endovascular treatments yield remarkable clinical results both at acute and 1-year follow-up. The best-suited revascularization strategy should be discussed in a multidisciplinary context, and chosen according to the clinical characteristics of each single case and local expertise.
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- 2015
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47. ANMCO/SICI-GISE paper on antiplatelet therapy in acute coronary syndrome
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De Luca, Leonardo, Bolognese, Leonardo, Valgimigli, Marco, Ceravolo, Roberto, Danzi, Gian Battista, Piccaluga, Emanuela, Rakar, Serena, Cremonesi, Alberto, Bovenzi, Francesco Maria, Cardiologists), Italian Association of Hospital, for the Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO, the Società Italiana di Cardiologia Invasiva (SIC, Abbate, R., Andreotti, F., Bolognese, L., Biondi-Zoccai, G., Bovenzi, F.M., Capodanno, D., Caporale, R., Capranzano, P., Carrabba, N., Casella, G., Cavallini, C., Ceravolo, R., Colombo, P., Conte, M.R., Cordone, S., Cremonesi, A., Danzi, G.B., Del Pinto, M., De Luca, G., De Luca, L., De Servi, S., Di Lorenzo, E., Di Pasquale, G., Esposito, G., Farina, R., Fiscella, A., Formigli, D., Galli, S., Giudice, P., Gonzi, G., Greco, C., Grieco, N.B., La Vecchia, L., Lazzari, M., Lettieri, C., Lettino, M., Limbruno, U., Lupi, A., Macchi, A., Marini, M., Marzilli, M., Montinaro, A., Musumeci, G., Navazio, A., Olivari, Z., Oltrona Visconti, L., Oreglia, J.A., Ottani, F., Parodi, G., Pasquetto, G., Patti, G., Perkan, A., Perna, G.P., Piccaluga, E., Piscione, F., Prati, F., Rakar, S., Ravasio, R., Ronco, F., Rossini, R., Rubboli, A., Saia, F., Sardella, G., Satullo, G., Savonitto, S., Sbarzaglia, P., Scorcu, G., Signore, N., Tarantini, G., Terrosu, P., Testa, L., Tubaro, M., Valente, S., Valgimigli, M., Varbella, F., and Vatrano, M.
- Abstract
Antiplatelet therapy is the cornerstone of the pharmacologic management of patients with acute coronary syndrome (ACS). Over the last years, several studies have evaluated old and new oral or intravenous antiplatelet agents in ACS patients. In particular, research was focused on assessing superiority of two novel platelet adenosine diphosphate (ADP) P2Y
12 receptor antagonists (i.e. prasugrel and ticagrelor) over clopidogrel. Several large randomized controlled trials have been undertaken in this setting and a wide variety of pre-specified and post hoc analyses are available that evaluated the potential benefits of novel antiplatelet therapies in different subsets of patients with ACS. The aim of this document is to review recent data on the use of current antiplatelet agents for in-hospital treatment of ACS patients. For each drug or class of drugs, strong evidence and/or areas of uncertainty that warrant further research are highlighted by examining 10 subgroups of patients with ACS.- Published
- 2014
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48. ESC Guidelines on the Diagnosis and Treatment of Peripheral Artery Diseases.
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Tendera, Michal, Aboyans, Victor, Bartelink, Marie-Louise, Baumgartner, Iris, Clément, Denis, Collet, Jean-Philippe, Cremonesi, Alberto, De Carlo, Marco, Erbel, Raimund, Fowkes, F. Gerry R., Heras, Magda, Kownator, Serge, Minar, Erich, Ostergren, Jan, Poldermans, Don, Riambau, Vincent, Roffi, Marco, Röther, Joachim, Sievert, Horst, and van Sambeek, Marc
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- 2012
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49. Carotid Stenting Using Radial Artery Access
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Castriota, Fausto, Cremonesi, Alberto, Manetti, Raffaella, Lamarra, Mauro, and Noera, Giorgio
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- 1999
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50. The First Consensus Document of ICCS-SPREAD Joint Committee on Carotid Artery Stenting was not premature but prophetic.
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Cremonesi A, Setacci C, de Donato G, Gensini GF, ICSS-SPREAD Joint Committee on Carotid Artery Stenting, Cremonesi, Alberto, Setacci, Carlo, de Donato, Gianmarco, and Gensini, Gian Franco
- Published
- 2008
- Full Text
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